MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. V-PRO; STERILIZER

Model Number	MAX 2
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and made minor repairs to the unit that were not correlated to the wet pack.The unit was tested, confirmed to be operating according to specification, and returned to service.Additionally, the employee subject of the reported event was not wearing the proper ppe, specifically gloves, while handling items that had been processed in the v-pro max 2 sterilizer.The operator manual states (1-2), "danger - chemical injury hazard: any visible liquids in the chamber or on the load must be treated as concentrated hydrogen peroxide.Observe all hydrogen peroxide handling precautions.When handling hydrogen peroxide, wear appropriate personal protective equipment." additionally, the v-pro max 2 sterilizer operator manual states (a-1), "a.Dry all items thoroughly.B.Ensure all moisture is removed from all internal parts (including lumens).If not, residual hydrogen peroxide may remain at cycle completion." a steris account manager counseled user facility personnel on the importance of wearing proper ppe, specifically gloves, while operating their v-pro max 2 sterilizer.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee experienced a burn after opening a pack that was previously processed in their v-pro max 2 sterilizer.The employee rinsed their hands with water and continued working.

• Brand Name: V-PRO
• Common Device Name: STERILIZER
• Manufacturer (Section D): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20668742
• Report Number: 3005899764-2024-00064
• Device Sequence Number: 15511870
• Product Code: MLR
• UDI-Device Identifier: 00724995158354
• UDI-Public: (01)00724995158354(11)211209
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAX 2
• Device Catalogue Number: VP50002101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown